Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound (PMCS EURO HEAL)
This study is currently recruiting participants.
Verified October 2012 by Halscion, Inc.
Sponsor:
Halscion, Inc.
Information provided by (Responsible Party):
Halscion, Inc.
ClinicalTrials.gov Identifier:
NCT01706848
First received: October 3, 2012
Last updated: October 17, 2012
Last verified: October 2012
| Tracking Information | |||||
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| First Received Date ICMJE | October 3, 2012 | ||||
| Last Updated Date | October 17, 2012 | ||||
| Start Date ICMJE | September 2012 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety [ Time Frame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: Yes ] Safety as defined by the incidence of device related adverse events. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01706848 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound | ||||
| Official Title ICMJE | A Post Market Clinical Study Evaluating the Safety, Device Performance and Possible Emergent Risks of Celotres in the Improvement of Wound Healing and the Resulting Scar Consequences Following Suturing of a Wound | ||||
| Brief Summary | The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to improve wound healing and the resulting scar consequences following suturing of a wound. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Scar | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Poland, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01706848 | ||||
| Other Study ID Numbers ICMJE | HAL-0297 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Halscion, Inc. | ||||
| Study Sponsor ICMJE | Halscion, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Halscion, Inc. | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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